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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sealant, Pit And Fissure, And Conditioner
510(k) Number K921600
Device Name ULTRADENT PROD LI CURED PIT/FISSURE SEAL PROD LINE
Applicant
Ultradent Products, Inc.
505 W. 10200 S.
South Jordan,  UT  84095
Applicant Contact LINDA CHATWIN
Correspondent
Ultradent Products, Inc.
505 W. 10200 S.
South Jordan,  UT  84095
Correspondent Contact LINDA CHATWIN
Regulation Number872.3765
Classification Product Code
EBC  
Date Received04/03/1992
Decision Date 09/28/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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